Literature article entitled, ¿structural femoral head allografts in revision surgery of loosened acetabular cups¿ by c.Wedemeyer, et al, published by the trauma surgeon (2007), vol.110, pp.104-110, was reviewed.The aim of the study was to assess the results after transplantation of allogenic structural femoral heads for the reconstruction of acetabular defects in hip replacement surgery performed between september 1992 and may 1995.In all cases, an allograft structural femoral head was used to fill an acetabular defect.This study involves acetabular cups from a variety of manufacturers.The acetabular cages used in 6 patients were competitor products.The manufacturer of the femoral heads is unknown.This article provides the patient information for all 35 patients.This complaint will capture the 3 patients and associated adverse events implanted with depuy products.The remaining cases provide insufficient information to determine the manufacturer of the acetabular cups used in the acetabular reconstruction and will not be included in the complaint.The authors do not provide information or outcomes for femoral stems.This complaint contains 3 total pcs labeled patient 9, patient 16, and patient 27 in the attached guidance document.Patient 9 is captured in (b)(4).Patient 16 and 27 are linked to parent (b)(4).Female patient implanted with duraloc cup and 4 acetabular screws.Preoperative diagnosis: acetabular paprosky defects 2c.Revised 8 months after index implantation to cemented polyethylene cup.Manufacturer of the cement and cup are unknown.
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Product complaint # (b)(4).Investigation summary = > no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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